Safety of biologic therapies during pregnancy in women with rheumatic disease

Table 1 Current European Medicines Agency recommendations about licensed biologic therapies and pregnancy (from http://www.ema.europa.eu/ema/)

Biologic drug	Recommendations for women of childbearing potential	Recommendations for the infant exposed in utero
Infliximab1	Adequate contraception for at least 6 mo after the last infusion	Neither live vaccines administration nor breast-feeding is recommended while treated and for 6 mo following the mother’s last infliximab infusion during pregnancy
Etanercept	To use appropriate contraception during therapy and for 3 wk after discontinuation of therapy	Neither live vaccines administration nor breast-feeding is recommended while treated and for 16 wk after the mother’s last dose of Enbrel is generally not recommended
Adalimumab2	Adequate contraception for at least 5 mo after the last injection	Neither live vaccines administration nor breast-feeding is recommended while treated and for 5 mo following the mother’s last injection during pregnancy
Golimumab	Adequate contraception for at least 6 mo after the last injection	Neither live vaccines administration nor breast-feeding is recommended while treated and for 6 mo following the mother’s last injection during pregnancy
Certolizumab	Adequate contraception for at least 5 mo after the last injection	Neither live vaccines administration nor breast-feeding is recommended while treated and for 5 mo following the mother’s last injection during pregnancy
Anakinra	Not recommended during pregnancy and in women of childbearing potential not using contraception	No data
Tocilizumab	Adequate contraception for at least 3 mo after the last infusion	A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman
		Advice about live vaccine use in newborns is not given
Rituximab	Adequate contraception for at least 12 mo after the last infusion	No breast-feeding is recommended while treated and for 12 mo following the mother’s last infusion during pregnancy
		Advice about live vaccine use in newborns is not given
Abatacept	Adequate contraception for at least 14 wk after the last dose	No breast-feeding is recommended while treated and for 14 wk following the mother’s last infusion during pregnancy
		Advice about live vaccine use in newborns is not given

¹Remicade^®, Inflectra^® and Remsima^®;

²Humira^® and Trudexa^®.